U.S. patent application number 16/963186 was filed with the patent office on 2021-04-29 for tool for servicing an auto-injector.
This patent application is currently assigned to Birya Biotech, Inc.. The applicant listed for this patent is Birya Biotech, Inc.. Invention is credited to John Hall, Tzvi Mordechai Urszuy.
Application Number | 20210121631 16/963186 |
Document ID | / |
Family ID | 1000005327831 |
Filed Date | 2021-04-29 |
![](/patent/app/20210121631/US20210121631A1-20210429\US20210121631A1-2021042)
United States Patent
Application |
20210121631 |
Kind Code |
A1 |
Urszuy; Tzvi Mordechai ; et
al. |
April 29, 2021 |
TOOL FOR SERVICING AN AUTO-INJECTOR
Abstract
An apparatus and method are provided for opening auto-injectors
for subsequent servicing and refilling with medicament. The
apparatus opens and disassembles an auto- injector to gain access
to its drug reservoir so that a replacement medicament may be
applied. The apparatus provides for reassembling the auto-injector
as a medical device for subsequent service.
Inventors: |
Urszuy; Tzvi Mordechai;
(Baltimore, MD) ; Hall; John; (Baltimore,
MD) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Birya Biotech, Inc. |
Baltimore |
MD |
US |
|
|
Assignee: |
Birya Biotech, Inc.
Baltimore
MD
|
Family ID: |
1000005327831 |
Appl. No.: |
16/963186 |
Filed: |
January 18, 2019 |
PCT Filed: |
January 18, 2019 |
PCT NO: |
PCT/US2019/014353 |
371 Date: |
July 17, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62619236 |
Jan 19, 2018 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2209/045 20130101;
A61M 5/3205 20130101; A61M 5/20 20130101; A61M 5/28 20130101 |
International
Class: |
A61M 5/20 20060101
A61M005/20; A61M 5/32 20060101 A61M005/32; A61M 5/28 20060101
A61M005/28 |
Claims
1. An apparatus for servicing an auto-injector, the apparatus
comprising: a base; a receiver coupled to the base and configured
to accommodate the auto-injector therein; a clamp coupled to the
base and configured to move from a first position in which the
clamp is in a non-clamped state to a second position in which the
clamp is in a clamped state, wherein, in the clamped state, the
clamp is configured to compress the auto-injector; and an extractor
coupled to the base and including a coupling device structured to
couple to an actuation assembly of the auto-injector, the extractor
being configured to pull the actuation assembly out of the
auto-injector with the coupling device.
2. The apparatus of claim 1, wherein the extractor comprises a
mandrel assembly including: a mandrel pin being configured to
prevent movement of a needle of the auto-injector.
3. The apparatus of claim 1, wherein the receiver includes an
insert disposed at one end of the receiver and configured to
receive a portion of an outer body of the auto-injector.
4. The apparatus of claim 1, wherein the clamp is configured to
exert force on the auto-injector and cause release of the actuation
assembly from an outer body of the auto-injector.
5. The apparatus of claim 4, wherein the force exerted on the
auto-injector by the clamp causes projections on the actuation
assembly to disengage from corresponding openings on the outer body
of the auto-injector so as to release the actuation assembly from
the outer body.
6. A method of servicing an auto-injector, comprising: inspecting
the auto-injector to determine whether the auto-injector is
serviceable, removing, via an apparatus, an actuation assembly from
a body of the auto-injector; disposing of existing medicament from
the auto-injector; refilling the auto-injector with medicament; and
re-inserting the actuation assembly into the auto-injector and
closing the auto-injector to render the auto-injector serviceable
for further deployment.
7. The method of claim 6, wherein disposing of existing medicament
comprises removing a needle of the auto-injector.
8. The method of claim 6, wherein disposing of existing medicament
comprises removing an internal plunger of the auto-injector. The
method of claim 6, wherein refilling of the auto-injector comprises
replacing an existing cartridge of the auto-injector storing the
existing medicament with a new cartridge.
10. The method of claim 6, wherein removal of the actuation
assembly comprises releasing the actuation assembly from an outer
body of the auto-injector.
11. The method of claim 6, wherein the apparatus comprises a clamp,
and wherein the method further comprises pressing the clamp of the
apparatus down on at least a portion of the auto-injector.
12. The method of claim 7, wherein the apparatus comprises an
extractor, and wherein the method further comprises extending at
least a portion of the extractor so as to contact the auto-injector
to remove the actuation assembly.
13. A method of using a tool for servicing an auto-injector, the
method comprising: placing the auto-injector in a receiver of the
tool; moving a clamp coupled to a base from a first position to a
second position, the first position being a position in which the
clamp is in a non-clamped state and the second position being a
position in which the clamp is in a clamped state, wherein, in the
clamped state, the clamp is configured to compress the
auto-injector; and coupling at least a portion of an extractor to
the auto-injector to pull an actuation assembly out of the
auto-injector with the coupled extractor.
14. The method of claim 13, further comprising removing a safety
pin disposed at an opening of the auto-injector.
15. The method of claim 13, further comprising clamping sides of an
outer body of the injector to cause deformation of the outer body
of the auto-injector.
16. The method of claim 15, wherein causing deformation of the
outer body comprises compressing the auto-injector.
17. The method of claim 15, wherein extracting the actuation
assembly comprises dislodging the actuation assembly from the outer
body while retaining one or more remaining components of the
auto-injector within the receiver.
18. The method of claim 13, further comprising inserting a safety
pin into a hole of the auto-injector to prevent deployment of a
needle of the auto-injector.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional
Patent Application No. 62/619,236 filed Jan. 19, 2018, the entire
contents of which are incorporated herein by reference.
FIELD
[0002] The present disclosure relates to servicing medical devices.
More particularly, the present disclosure relates to a method and
apparatus for opening auto-injectors for refilling with medicament
upon activation. Disclosed embodiments provide for reassembling the
auto-injector as a functional medical device for subsequent
service.
BACKGROUND
[0003] An automatic injector or auto-injector is a device designed
to allow a user to self-administer a pre-measured dose of a
medicament composition subcutaneously or intramuscularly, often in
an emergency situation. Automatic injectors are used for example,
to treat anaphylactic (severe allergic) reactions and to administer
antidotes for certain poisons, such as chemical nerve agents and
various drug compositions such as diazepan.
[0004] Thus, an auto-injector automatically dispenses a
predetermined dose of medicament upon activation. The auto-injector
may include a needle cover operative to engage an injection site
and activate the injector. The needle cover may be configured to
move from a locked retracted position prior to a medicament
dispensing operation to a locked extended position after the
medicament dispensing operation. The non-removable needle cover may
prevent contact with the needle both before and after the
medicament dispensing operation.
[0005] Auto-injectors are constructed to be tamper proof and
resistant to damage while also being intended for disposal after
use or expiry. Such disposal of auto-injectors after use or expiry
produces large amounts of waste material and does not contribute to
cost efficacy. Thus, there is a need for providing a method and
apparatus for opening, disassembling and reassembling
auto-injectors in a manner that enables the medical devices to be
easily serviced and reassembled in a manner that is conducive to
being refilled and reliably used.
SUMMARY
[0006] In at least one embodiment, an apparatus for servicing an
auto-injector is provided. The apparatus includes a base; a
receiver coupled to the base and configured to accommodate the
auto-injector therein; a clamp coupled to the base and configured
to move from a first position in which the clamp is in a
non-clamped state to a second position in which the clamp is in a
clamped state, wherein, in the clamped state, the clamp is
configured to compress the auto-injector; and an extractor coupled
to the base and including a coupling device structured to couple to
an actuation assembly of the auto-injector, the extractor being
configured to pull the actuation assembly out of the auto-injector
with the coupling device.
[0007] In at least one embodiment, a method of servicing an
auto-injector is provided. The method includes inspecting the
auto-injector to determine whether the auto-injector is
serviceable; removing, via an apparatus, an actuation assembly from
a body of the auto-injector; disposing of existing medicament from
the auto-injector; refilling the auto-injector with medicament; and
re-inserting the actuation assembly into the auto-injector and
closing the auto-injector to render the auto-injector serviceable
for further deployment.
[0008] In at least one embodiment, a method of using a tool for
servicing an auto-injector, is provided. The method includes
placing the auto-injector in a receiver of the tool; moving a clamp
coupled to a base from a first position to a second position, the
first position being a position in which the clamp is in a
non-clamped state and the second position being a position in which
the clamp is in a clamped state, wherein, in the clamped state, the
clamp is configured to compress the auto-injector; and coupling at
least a portion of an extractor to the auto-injector to pull an
actuation assembly out of the auto-injector with the coupled
extractor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The accompanying drawings, which are incorporated herein and
constitute part of this specification, illustrate exemplary
embodiments of the disclosure, and, together with the general
description given above and the detailed description given below,
serve to explain the features of the disclosure.
[0010] FIG. 1 is a side cross sectional view of an exemplary
auto-injector, according to an embodiment of the present
disclosure.
[0011] FIG. 2 is a side schematic view of the auto-injector in the
unactivated state of FIG. 1, according to an embodiment of the
present disclosure.
[0012] FIG. 3 is a side view of an exemplary release pin, according
to an embodiment of the present disclosure.
[0013] FIG. 4 is another side view of the release pin of FIG. 3
rotated about an axis, according to an embodiment of the present
disclosure.
[0014] FIG. 5 is a bottom perspective view of the safe release pin
of FIG. 3, according to an embodiment of the present
disclosure.
[0015] FIG. 6 is a left side perspective view of the exemplary
outer body of the auto-injector, according to an embodiment of the
present disclosure.
[0016] FIG. 7 is a partial cross sectional perspective view
illustrating the interior of the exemplary outer body of the
auto-injector, according to an embodiment of the present
disclosure.
[0017] FIG. 8 is a side view of the outer body of the exemplary
outer body of the auto-injector, according to an embodiment of the
present disclosure.
[0018] FIG. 9 is another side view of the exemplary outer body of
the auto-injector of FIG. 8 rotated 90 degrees about an axis,
according to an embodiment of the present disclosure.
[0019] FIG. 10 is a left rear perspective view of the power pack
outer body for an exemplary power pack for the auto-injector,
according to an embodiment of the present disclosure.
[0020] FIG. 11A is a right front perspective view of the power pack
inner body for the exemplary power pack for the auto-injector,
according to an embodiment of the present disclosure.
[0021] FIG. 11B is a partial cross sectional perspective view of
the power pack inner body for the exemplary power pack for the
auto-injector, according to an embodiment of the present
disclosure.
[0022] FIG. 11C is a partial cross sectional perspective view of
the power pack inner body for the exemplary power pack for the
auto-injector, according to an embodiment of the present
disclosure.
[0023] FIG. 11D is a side perspective view of the power pack inner
body for the exemplary power pack for the auto-injector, according
to an embodiment of the present disclosure.
[0024] FIG. 12 is a side perspective view of the collet for the
exemplary power pack for the auto-injector, according to an
embodiment of the present disclosure.
[0025] FIG. 13 is a side perspective view of the spring assembly
for the exemplary power pack for the auto-injector, according to an
embodiment of the present disclosure.
[0026] FIG. 14 is a right bottom perspective view of an exemplary
power pack of the auto-injector in an assembled state, according to
an embodiment of the present disclosure.
[0027] FIG. 15 is a side cross sectional view of the exemplary
power pack of FIG. 14, according to an embodiment of the present
disclosure.
[0028] FIG. 16 is a top left perspective view of the exemplary
power pack of FIG. 14 having the top portion of the release pin and
a peripheral rib of the power pack outer body removed, according to
an embodiment of the present disclosure.
[0029] FIG. 17 is a top left perspective view of the exemplary
power pack of FIG. 14, according to an embodiment of the present
disclosure.
[0030] FIG. 18 is a top left perspective view of the exemplary
power pack positioned within the outer body having the safe pin
removed, according to an embodiment of the present disclosure.
[0031] FIG. 19 illustrates a perspective view of an apparatus for
servicing an auto-injector, according to an embodiment of the
present disclosure.
[0032] FIG. 20 illustrates a bottom view of the apparatus of FIG.
19 for servicing an auto-injector, according to an embodiment of
the present disclosure.
[0033] FIG. 21 illustrates a top view of the apparatus of FIG. 19
for servicing an auto-injector, according to an embodiment of the
present disclosure.
[0034] FIG. 22 illustrates a front view of the apparatus of FIG. 19
for servicing an auto-injector, according to an embodiment of the
present disclosure.
[0035] FIG. 23 illustrates a back view of the apparatus of FIG. 19
for servicing an auto-injector, according to an embodiment of the
present disclosure.
[0036] FIG. 24 illustrates a right end view of the apparatus of
FIG. 19 for servicing an auto-injector, according to an embodiment
of the present disclosure.
[0037] FIG. 25 illustrates a left end view of the apparatus of FIG.
19 for servicing an auto-injector, according to an embodiment of
the present disclosure.
[0038] FIG. 26 is an enlarged view of the extractor clamp assembly
and extractor handle assembly of the apparatus of FIG. 19 for
servicing an auto-injector, according to an embodiment of the
present disclosure.
[0039] FIG. 27 is a cross-cut view of the extractor clamp assembly
and extractor handle assembly of FIG. 26, according to an
embodiment of the present disclosure.
[0040] FIG. 28 illustrates a modified top view of the apparatus of
FIG. 19 for servicing an auto-injector, according to an embodiment
of the present disclosure.
[0041] FIG. 29 is an enlarged view of the extractor clamp assembly
of FIG. 28, according to an embodiment of the present
disclosure.
[0042] FIG. 30 illustrates a perspective view of another embodiment
of an apparatus for servicing an auto-injector, according to an
embodiment of the present disclosure.
[0043] FIG. 31 illustrates a top view of the apparatus of FIG. 30
for servicing an auto-injector, according to an embodiment of the
present disclosure.
[0044] FIG. 32 illustrates a front view of the apparatus of FIG. 30
for servicing an auto-injector, according to an embodiment of the
present disclosure.
[0045] FIG. 33 illustrates a modified top view of the apparatus of
FIG. 30 for servicing an auto-injector, according to an embodiment
of the present disclosure.
[0046] FIG. 34 is an enlarged view of the extractor clamp assembly
of FIG. 33, according to an embodiment of the present
disclosure.
[0047] FIG. 35 is a bottom perspective view of a mandrel safety pin
assembly employed by the apparatus of FIG. 30 for servicing the
auto-injector, according to an embodiment of the present
disclosure.
[0048] FIG. 36 is a cut-away view of the mandrel safety pin
assembly of FIG. 35, according to an embodiment of the present
disclosure.
[0049] FIG. 37 illustrates a safe release pin removed from an
exemplary auto-injector, according to an embodiment of the present
disclosure.
[0050] FIG. 38 is a cut-away view of the mandrel safety pin
assembly in connection with the power pack of the auto-injector,
according to an alternate embodiment of the present disclosure.
[0051] FIG. 39 illustrates an exemplary power pack removed from the
auto-injector body by the apparatus of FIGS. 19 and 30, according
to an embodiment of the present disclosure.
[0052] FIG. 40 is a flowchart illustrating various techniques for
refilling medicament in an auto-injector, according to an
embodiment of the present disclosure.
DETAILED DESCRIPTION
Definitions
[0053] Where the definition of terms departs from the commonly used
meaning of the term, applicant intends to utilize the definitions
provided below, unless specifically indicated.
[0054] It is to be understood that the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of any subject matter
claimed. In this application, the use of the singular includes the
plural unless specifically stated otherwise. It must be noted that,
as used in the specification and the appended claims, the singular
forms "a," "an" and "the" include plural referents unless the
context clearly dictates otherwise. In this application, the use of
"or" means "and/or" unless stated otherwise. Furthermore, use of
the term "including" as well as other forms, such as "include",
"includes," and "included," is not limiting.
[0055] For purposes of the present disclosure, the term
"comprising", the term "having", the term "including," and
variations of these words are intended to be open-ended and mean
that there may be additional elements other than the listed
elements.
[0056] For purposes of the present disclosure, directional terms
such as "top," "bottom," "upper," "lower," "above," "below,"
"left," "right," "horizontal," "vertical," "up," "down," etc., are
used merely for convenience in describing the various embodiments
of the present disclosure. The embodiments may be oriented in
various ways. For example, the diagrams, apparatuses, etc., shown
in the drawing figures may be flipped over, rotated by 90.degree.
in any direction, reversed, etc.
[0057] For purposes of the present disclosure, a value or property
is "based" on a particular value, property, the satisfaction of a
condition, or other factor, if that value is derived by performing
a mathematical calculation or logical decision using that value,
property or other factor.
[0058] For purposes of the present disclosure, it should be noted
that to provide a more concise description, some of the
quantitative expressions given herein are not qualified with the
term "about." It is understood that whether the term "about" is
used explicitly or not, every quantity given herein is meant to
refer to the actual given value, and it is also meant to refer to
the approximation to such given value that would reasonably be
inferred based on the ordinary skill in the art, including
approximations due to the experimental and/or measurement
conditions for such given value.
[0059] For purposes of the present disclosure, the term
"associated" with respect to data refers to data that are
associated or linked to each other. For example, data relating the
identity of an individual (identity data) wearing an integrated
sensor module may be associated with the motion data for the
individual obtained from an accelerometer or, optionally, from a
gyroscope or, optionally, from the amplitude of the power signal
from an energy harvester.
[0060] For the purposes of the present disclosure, the term
"elastic deformation" refers to a temporary shape change that is
self-reversing after the force is removed, so that the object
returns to its original shape.
Description
[0061] While the disclosure is open to various modifications and
alternative forms, specific embodiments thereof have been shown by
way of example in the drawings and will be described in detail
below. However, it should be understood that the disclosure is not
intended to limit the disclosure to the particular forms disclosed,
but on the contrary, the disclosure is to cover all modifications,
equivalents, and alternatives falling within the spirit and the
scope of the disclosure.
[0062] Disclosed embodiments provide a method and apparatus for
opening auto-injectors for subsequent servicing and refilling with
medicament. The disclosed apparatus will open and disassemble
auto-injectors to gain access to its drug reservoir so that a
replacement pharmaceutical may be applied. Disclosed embodiments
provide for reassembling the auto-injector as a functional medical
device. In some embodiments, the disclosed apparatus is configured
to compress the outer body of the auto-injector such that at least
a portion of the outer body is deformed enough for the actuation
assembly to be released. In this manner, the elastic deformation
allows a power pack (e.g., an actuation assembly) that seals the
end of the auto-injector to slide out once the latching pins of the
power pack clear the outer shell. In some disclosed embodiments,
the exterior outer body comprises a malleable plastic shell of the
auto-injector. After the shell is compressed, the power pack is
removed by extending a mandrel through a hole in the power pack
which serves as a safety/arming pin of the auto-injector. The
mandrel is then expanded and grips the inside of the power pack
(i.e., couples to the interior of the power pack) thereby creating
enough traction and pulling force to slide the power pack from the
shell for removal. In one disclosed embodiment, clamps may be
utilized to grip the power pack from the outside in order to gain
sufficient traction necessary to remove the power pack from the
shell. Additionally, the clamps may be configured to fit latching
pins to form a supplementary angle that facilitates both the
compression and sliding of pins under the expanded shell.
[0063] A typical auto-injector has a housing which contains, for
example, a drug reservoir which may be a cartridge. The cartridge
has one or several chambers containing medicament compositions or
components thereof and is adapted to be attached to a needle
assembly. The cartridge can hold, for example, a pre-mixed liquid
medicament or a solid medicament and a liquid that are mixed prior
to injection. In some implementations, the cartridge may hold a
plurality of liquids, or a plurality of solids, or combinations
thereof. The housing carries an actuation assembly with a stored
energy source, for example, a compressed spring. Activation of the
actuation assembly causes a sequence of movements, whereby the
needle extends from the auto-injector into the user so that the
medicament compound is then forced through the needle and into the
user. In some implementations, after delivery of the dose of
medicament into the injection site the needle may remain in an
extended position, whereas in alternative implementations, the
needle may retract or otherwise be covered, e.g., by a shield. If
the auto-injector is of the type designed to carry plural
components of the medicament composition in separate, sealed
compartments, structure may be included that forces the components
to mix when the actuation assembly is activated.
[0064] One aspect of the present disclosure relates to an
auto-injector for dispensing a predetermined dosage of a
medicament. The medicament may be either self-administered or
administered by a caregiver. The auto-injector includes a housing.
The housing may comprise an oval or elliptical shape such that it
is more ergonomic. The oval shape prevents the auto-injector from
rolling off a table or flat surface, while providing a larger
surface area for printing user instructions. A cartridge container
is disposed within the housing. A cartridge is received within the
cartridge container. The cartridge has at least one opening therein
and contains a medicament. The medicament is rearwardly confined by
a plunger. The cartridge includes a needle assembly to dispense the
medicament there through. The cartridge is advanced within the
cartridge container from a stored position to an operation position
where the needle extends from the cartridge container such that the
dose of medicament can be administered. An actuation assembly or
power pack provides a stored energy source that is capable of being
released to drive the plunger within the cartridge to dispense the
medicament through the needle assembly into the user and allowing
the needle to be accessible on activation.
[0065] Another aspect of the present disclosure is the construction
and arrangement of the actuation assembly or power pack, which is
mounted within the housing adjacent to an open end. A release pin
or safe pin is removably attached to the actuation assembly to
prevent inadvertent actuation of the auto-injector when the release
pin is in place. A pin or stem on the release pin is received
within an opening in the actuation assembly to prevent actuation of
the auto-injector. This opening in the power pack (which may be
described as an actuation assembly or actuator) is spaced from the
open end of the housing such that the opening is less visible to a
user prior to administering the drug. This arrangement is provided
so that user will not orient the incorrect end of the auto-injector
against the injection surface of the user. The power pack is
recessed or spaced from the end of the housing, which provides an
indication to the user that pressing the power pack will not
operate the auto-injector. The recessed nature of the power pack
serves to hide the release pin hole in the power pack when the user
is viewing the instructions on the outer body such that the user
does not confuse the release pin hole with the opening through
which the needle passes for administering the medicament. The
release pin may include at least one tab extending therefrom. The
tab is compression fit into a complementary recess formed in the
actuation assembly to prevent the inadvertent removal of the
release pin. The tabs also prevent rotation of the release pin such
that the user easily recognizes that the release pin must be pulled
in order to be removed.
[0066] The actuation assembly includes an outer body, which is
configured to engage the release pin. The outer body is constructed
to be connected to the housing. An inner body is operatively
coupled to the outer body. At least one retention tab on the inner
body secures the inner body to the outer body. The inner body is
capable of limited movement with respect to the outer body. A
collet is operatively coupled to the inner body. An energy source
is operatively connected to the inner body and the collet. In some
disclosed embodiments, the collet may be molded as a single piece.
No spacers or other components are provided between the collet and
the plunger in the cartridge. This arrangement simplifies
construction. Different sized collets can be produced and installed
into the actuation assembly, such that only the collet needs to be
altered when different sized cartridges are used or a different
sized dosage of medicament is to be administered.
[0067] An exemplary auto-injector 100 will now be described in
greater detail in connection with FIGS. 1-2 and 6-9. The
auto-injector 100 includes an outer body 110, a release pin (a
release pin assembly) 120, a power pack 130, a cartridge container
140, a needle cover 150 and a cartridge 160 housing a dose of
medicament. The dose can be stored in liquid or solid form or as a
combination of a liquid and a solid that is mixed prior to
injection. In some embodiments, the dose may be stored as a
combination of a plurality of liquids, a combination of a plurality
of solids, or a combination of a plurality of liquids and
solids.
[0068] The exemplary auto-injector 100 may include an outer body.
The outer body 110 may include a generally oval or elliptical
shape, which is more ergonomic sized to permit easy grasping and
use by the user or caregiver in comparison with a cylindrical body.
The generally oval shape of the outer body 110 prevents the
auto-injector 100 from inadvertently rolling or sliding off a flat
surface. Furthermore, the oval shape provides a larger print
surface for labeling the auto-injector 100 with instructions. The
outer body 110 is preferably formed from a synthetic material such
that it can be easily molded. The outer body 110 can be transparent
such that the interior components can be easily viewed through the
outer body 110. With such a construction, the user can view the
contents of the cartridge 160 through windows in the cartridge
container 140 and the needle cover 150 at predetermined times. It
is also contemplated that the outer body 110 can be opaque such
that the interior components are not visible through the outer body
110. It is also contemplated that the outer body 110 has a window
or windows that permit viewing of the components within the outer
body 110. The outer body 110 has an opening 111 formed in one end
that is sized to receive a release pin 120. When in place, the
release pin 120 prevents inadvertent use or activation of the
auto-injector 100.
[0069] An exemplary detailed embodiment of the release pin 120 is
illustrated in FIGS. 3-5. The release pin 120 may include
downwardly projecting ribs 122a and 122b, which are adapted to be
received on the top surface of the power pack 130. The ribs 122a
and 122b increase the stability and rigidity of the release pin
120. It is contemplated that additional ribs may be provided. The
release pin 120 may include an outwardly facing flat end 123 having
a peripheral ledge 124. The peripheral ledge 124 permits grasping
of the release pin 120 by the user. The ledge 124 is sized to rest
on the end surface of the outer body 110 adjacent opening 111. The
release pin 120 includes a downwardly extending pin 125, which
engages the collet 430 of the power pack 130. When secured in place
(i.e., prior to removal of the release pin 120 and prior to
actuation of the auto-injector 100), the downwardly extending pin
125 prevents the end of the collet 430 from compressing, which
prevents actuation of the auto-injector 100. The end 123 has a
shape corresponding to the oval/elliptical shape of the outer body
110.
[0070] Turning to FIGS. 6-9, the opening 111 includes side recesses
111a and 111b, which extend downwardly along opposing sides of the
outer body 110. While two recesses are shown, it is contemplated
that a single recess may be provided or more than two may be
provided. The number of recesses will, correspond to the number of
tabs. The recesses 111a and 111b are sized so that they may receive
downwardly extending tabs 121a and 121b on the release pin 120. The
tabs 121a and 121b prevent rotation of the release pin 120 such
that the user easily recognizes that the release pin 120 is to be
pulled rather than rotated to permit removal of the release pin 120
in order to actuate the auto-injector 100. The tabs 121a and 121b
are primarily received in retention recesses 235 located on
opposing sides of the power pack 130, described in greater detail
below. The recesses 111a and 111b provide access to tabs 121a and
121b in the recesses 235. The tabs 121a and 121b are compression
fit onto the power pack 130 to prevent inadvertent removal. To
release the release pin 120, the operator compresses or pinches the
tabs 121a and 121b to dislodge the edges of the tabs 121a and 121b
from the recesses 235 such that the release pin 120 can then be
pulled/removed from the power pack 130. As shown, the tabs 121a and
121b have a curvature which creates a chamfered edge that engages
the edges of the recesses 235. The shape of the tabs 121a and 121b
and the recesses 235 are fully complementary, which creates the
friction or compressive retaining force between the pin 120 and
power pack 130.
[0071] In an exemplary embodiment, the inner surface of the outer
body 110 is contoured to receive the power pack 130, a cartridge
container 140 and a needle cover therein 150. The needle cover 150
may be positioned between the container 140 and the outer body 110.
Additionally, the mechanisms for locking and deploying the cover
member may be located within the outer body 110 and are thus
protected against tampering and contamination, such as dirt
ingress. The outer body 110 includes a cartridge container
retention step 112 formed on the inner surface near the end of the
outer body 110 adjacent the opening 111. A ledge 142 of the
cartridge container 140 abuts the retention step 112 to limit the
downward movement of the cartridge container 140 within the outer
body 110 once the auto-injector 100 has been assembled such that
the container cannot be moved out of opening 114. A plurality of
power pack retention openings 113a, 113b and 113c are formed on at
least one side of the outer body 110. Projections or teeth 238 on
the power pack 130 are snap fit into the openings 113. This snap
fit prevents the removal of the power pack 130 from the outer body
110 once installed in the outer body 110. The power pack outer body
230 is not movable with respect to the outer body 110. The ledge
142 of the cartridge container 140 is sandwiched between the
retention step 112 and the power pack 130.
[0072] An exemplary power pack 130 will now be described in greater
detail in connection with FIGS. 10-18. The power pack 130 according
to some embodiments may include structural components as described
in U.S. Pat. No. 7,449,012 to Young et al. The power pack 130 may
include a power pack outer body 230, a power pack inner body 330, a
collet 430, and a power pack spring assembly 530. In one exemplary
embodiment, the activation force necessary to release the energy
stored in the power pack is between 4 to 8 pounds. The activation
force is the force required to release the collet 430 from the
inner body 330 when the auto-injector 100 is pressed against the
injection surface. The injection force provided by the spring
assembly 530 is approximately 30 pounds. The injection force must
be sufficient such that the cartridge 160 is advanced within the
cartridge container 140 to drive the needle such that it pierces
the sheath to permit injection of the medicament into the user. The
power pack outer body 230 is a generally cylindrical elongated
hollow body 231. A plurality of outer peripheral ribs 232a, 232b
and 232c shown in FIG. 11B extend outwardly from an outer surface
of the hollow body 231. While these ribs 232 are shown, it is
contemplated additional ribs may be provided. The ribs 232 are
provided to prevent distortion of the outer body 110 of the
auto-injector 100. A plurality of outer longitudinal ribs 233a,
233b is spaced about the outer surface of the hollow body 231. The
ribs 233 cooperate with the ribs 232 to further strengthen the
auto-injector 100 and prevent distortion of the outer body 110 when
gripped and used by a user.
[0073] One of the peripheral ribs 232a forms a top end surface 237
of the power pack outer body 230. A hole 234 is provided in end
surface which is sized to receive the downwardly extending pin 125
of the release pin 120. Retention recesses 235a and 235b are formed
on opposing sides of the hollow body 231 adjacent the top end
surface. The recesses 235a and 235b are formed by walls 236a and
236b which extend outwardly from the hollow body 231 and upwardly
from the top end surface 237 of the peripheral rib 232a. The
recesses 235a and 235b are aligned with the side recesses 111a and
111b of the outer body 110 such that when the release pin 120 is
secured to the auto-injector 100, the tabs 121a and 121b are
received in both recesses 235a and 235b. The recesses 235a and 235b
are sized to apply a compressive force on the tabs 121a and 121b to
secure the release pin 120 in place to prevent inadvertent
removal.
[0074] A plurality of projections or teeth 238a, 238b, 238c is
formed on the outer surface of the hollow body 231, as shown in
FIG. 17. The teeth 238a, 238b, and 238c are sized to be snap fit
into the openings 113a, 113b, and 113c, respectively, to secure the
power pack 130 within the outer body 110. This construction permits
these components 110 and 130 to be secured together without the
need of an adhesive of other form of bonding. However, in some
embodiments, a bond may be formed, e.g., with adhesive, and one or
more of the teeth 238a, 238b, 238c and of the openings 113a, 113b,
113c may be omitted. A corresponding set of teeth may be provided
or the opposite side of the hollow body 230 to match the
corresponding openings in the outer body 110.
[0075] The interior of the hollow body 231 may include a recess
231a as shown in FIG. 11B, which is sized to receive a retention
tab 334 (shown in FIG. 11B) on the power pack inner body 330. The
recess 231a may be a groove, which extends about the inner
periphery of the hollow body 231. The recess 231a is positioned in
the hollow body 231 near an end opposite the end surface 237. As
seen in FIGS. 1 and 10, a collet activation structure extends into
the interior of the hollow body 231 from the inner side of the end
surface 237. The collet activation structure has a generally
cylindrical shape with a sloped collet activation surface located
on a free end. The activation surface is provided such that when
the pin 120 is removed and the front end of the injector is forced
into an injection site so that cartridge container 140 rearwardly
moves to engage inner body 330, this will rearwardly force tips of
the collet 430 (described later) and particularly rearward surfaces
thereof into engagement with activation surface to force the tips
of the collet 430 together to release the spring assembly 530 and
thus release the necessary energy to inject the medicament into the
user. Ribs may be provided to reinforce the collet activation
structure. It is contemplated that other means of releasing the
collet 430 may be employed. A push button type actuation
arrangement may be employed, which is described in greater detail
in U.S. Pat. No. 4,031,893, which is incorporated by reference
herein in its entirety for the background and techniques disclosed
therein.
[0076] The power pack inner body 330 is a generally cylindrical
hollow inner body 331. The hollow inner body 331 includes an
opening 333 shown in FIG. 11A extending from a first end thereof to
a second end thereof which is opposite to the first end. At the
first end of the inner body 331, the opening has a collet assembly
lead-in surface 332a as shown in FIG. 11D, which is used to
compress a portion of the collet assembly 430 during assembly of
the auto-injector 100 such that is can be properly mounted within
the power pack inner body 330. As shown in FIG. 11C, the opening
also has a collet retention surface 332b located on an external
surface of the inner body 331, and the collet retention surface
332b supports the opposing tips (finial portions which may be
shaped as arrowheads) 434a, 434b (shown in FIG. 15) of the collet
430 prior to activation. The opening of the hollow inner body 331
is positioned so as to be spaced from a plurality of retention tabs
334 which are sized to be snapped into the retention recess 231a.
The recess 231 and tabs 334 permit limited movement between the
power pack inner body 330 and the power pack outer body 230. The
arrangement is also beneficial for purposes of assembling the
auto-injector 100. The inner body 330 and the outer body 230 can be
preassembled. The recess 231 and tabs 334 maintain the inner body
330 and the outer body 230 in proper alignment for assembly.
Furthermore, this arrangement prevents the subassembly of the inner
body 330 and the outer body 230 from separating prior to the final
assembly in the auto-injector 100. It is also contemplated that
other means which permit limited movement between outer and inner
bodies of the power pack 130 (i.e., the actuation assembly), and
which secure the components together, may be employed. A ledge 335
at least partially extends about the periphery of the opening. The
ledge 335 is sized to engage the cartridge container 140 and the
power pack outer body 230 at certain times during the operation of
the auto-injector 100, described in greater detail below. A spacing
exists between the inner power pack 330 and the cartridge container
140 after assembly and prior to activation of the auto-injector 100
to create a gap, which avoids permanently putting forces on the
power pack and the spring 530.
[0077] A collet 430 as shown in FIG. 12 may be received within the
hollow interior of the power pack inner body 330. In some disclosed
embodiments, the collet 430 may be a molded one-piece construction.
The collect 430 has an elongated body 431 having an opening 432
formed therein which forms a pair of side arms 433a and 433b. Each
side arm 433a and 433b includes tips 434a and 434b (finial
portions) respectively. One side of each tip 434a and 434b is
configured to contact and engage the collet retention surface 332b.
An opposite side of each tip 434a and 434b is configured to engage
the collet assembly lead-in surface 332a, which permits the side
arms 433a and 433b to be deflected inwardly to permit operation of
the auto-injector 100. The end 435 of the collet 430 adjacent the
tips 434a and 434b includes an opening 435a sized to receive the
pin 125 of the release pin 120. The pin 125 prevents the side arms
433 from being deflected inwardly towards each other. When secured
in place, the pin 125 prevents activation of the auto-injector
100.
[0078] The collet 430 is positioned within the power pack spring
assembly 530. One end of the spring assembly 530 is supported on a
flange 436 formed on the collet 430. The flange 436 extends
outwardly from the elongated body 431. While the flange 436
supports one end of the spring assembly 530, the location of the
flange 436 on the body 431 can also serve to define the delivered
dose volume of medicament injected into the user. In certain
applications it is desirable to control the amount of medicament
delivered through the needle such that a portion of the medicament
remains in cartridge 160. The flange 436 may limit the distance
that the collet 430 can travel into the cartridge 160, which
contains the liquid medicament. As such, the amount of medicament
delivered is controlled. In this arrangement, the flange 436 is
sized to contact the end of the cartridge 160. For larger diameter
cartridges and for larger doses of medicament, it is contemplated
that the flange 436 can travel within the cartridge 160. The collet
430 further includes a projection 437, which receives a plunger
438. The plunger 438 is slidably received within the cartridge 160.
In other applications, it is desirable to dispense all of the
medicament from the container 160. A small residual amount of
medicament remains in the needle 162 and the neck of the cartridge
160 adjacent the needle 162. In these applications, the flange 436
travels within the interior of the cartridge 160 so that the
plunger 438 travels the length of the interior of the cartridge 160
to dispense all of the medicament (except for the residual amounts
mentioned above) through the needle 162. It is contemplated that
different sized collets 430 may be used in the present
auto-injector 100. As such, the collet 430 can be changed based
upon cartridge size and desired dose.
[0079] The collet 430 may be formed as a single piece from a
suitable plastic material. The one-piece collet 430 simplifies
manufacturing and lowers costs by reducing the number of components
needed to form a collet. In conventional collets, multiple brass
components may be used. In addition, in other conventional
auto-injectors, a spacer may be required for use in conjunction
with the collet 430 to accommodate different amounts of medicament
for different auto-injectors. The disclosed exemplary collet 430,
however, eliminates the multi component construction and also
advantageously eliminates the need for a spacer. The length of the
collet can be selected based upon the desired dosage. This
construction further permits the elimination of a metal insert
typically found in the plunger and a firing seat above the power
pack inner body. It is contemplated that the size and shape of the
collet 430 itself may be varied to accommodate different sized
cartridges 160. When the flange 436 does not contact the cartridge
160, it is possible to dispense the entire contents of the
cartridge 160 except for any residual amounts remaining in the
needle or in the neck of the cartridge 160. It is contemplated that
a nipple plunger, as disclosed in U.S. Pat. No. 5,713,866 to
Wilmot, the entire disclosure of which is incorporated herein by
reference for the background and techniques disclosed therein, may
be employed prevent any buildup of residual amounts of medicament
in the neck of the cartridge 160. The position of the flange 436
can be varied to control the amount of dosage injected into the
user when the flange is positioned such that the collet and the
plunger 438 travel a greater distance within the cartridge 160
before the flange 436 contacts the cartridge 160, a larger dose is
dispensed. The length of the collet 430 and the diameter of the
cartridge 160 can be selected to control the flow of fluid through
the needle 162 of the cartridge 160 so that a desired flow rate is
obtained. The auto-injector 100 in accordance with one or more
embodiments is configured such that collets 430 of varying sizes
can be used within the same outer body 110 and the power pack
430.
[0080] An opposite end of the spring assembly 530 rests against an
inner surface of the power pack inner body 330 against the
opening.
[0081] In general, auto-injectors are constructed to be tamper
proof and resistant to damage while also being intended for
disposal after use or expiry. Being able to open and reassemble an
auto-injector will allow it to be serviced or refilled with
medicament instead of necessitating the disposal of the
auto-injector. The apparatus of one or more embodiments can service
auto-injectors by opening/disassembling them in a manner to be
serviced and reassembled so that the auto-injector can be refilled
and reliably used.
[0082] Turning now to FIGS. 19-29, an embodiment of the disclosed
tool or apparatus 1900 for servicing an exemplary auto-injector 100
is illustrated. Components of apparatus 1900 may be
disposed/affixed on a service table (a base or support base) 1902.
Service table 1902 may include stabilizing feet 1904 to provide
stability and function as anti-friction stop surfaces to service
table 1902. Stabilizing feet 1904 may be affixed to an undersurface
of service table 1902 by one of a variety of retaining fixtures
including, for example, threaded fasteners 1906 and/or
alternatively, adhesives, hook and fastener materials or any other
structure sufficient to retain stabilizing feet 1904 at prescribed
locations along service table 1902.
[0083] Additional components secured to a top side 1908 of service
table 1902 include an end stop 2102, hold down cavity 1912 (i.e., a
receiver), restraining and device deforming clamp assembly 1914,
and extractor handle assembly 1916. As illustrated in FIG. 20, a
bottom view 2000 of apparatus 1900 illustrates that each of the end
stop 2102, hold down cavity 1912, restraining and device deforming
clamp assembly 1914, and extractor handle assembly 1916 may be
affixed to service table 1902 by one of a variety of retaining
fixtures including, for example, threaded fasteners 2002, secured
through the underside 2004 of service table 1902. Slots 2006 may be
provided in the service table 1902 to allow for adjustability and
multi-positioning of end stop 2102 and extractor handle assembly
1916. Such adjustability and multi-positioning may accommodate
various lengths of auto-injectors 100 and an ability to more
precisely control applied extraction forces from extractor handle
assembly 1916.
[0084] In at least one embodiment, hold down cavity 1912 as shown
in FIG. 23 is a receiver that accommodates auto-injector 100
disposed within a cavity 1910 designed to generally receive a
portion of outer body 110 of auto-injector 100. Hold down cavity
1912 may also include an interchangeable cavity insert 1918 as
shown in FIG. 22. Interchangeable cavity insert 1918 is designed to
take up slack and allow for outer body 110 expansion, for example,
generally in a deformation area 1920 of outer body 110. In some
disclosed embodiments, interchangeable cavity insert 1918 may
include a different material from hold down cavity 1912 to
accommodate flexible outer body 110 deformation, for example,
during a retaining, deformation and/or compression operation, as
described below. In some embodiments, the interchangeable insert
1918 may be incorporated into the receiver 1912.
[0085] Restraining and device deforming clamp assembly 1914
includes hold down clamp die (clamp) 1922. Hold down clamp die 1922
is mechanically coupled (such as via a series of pins, pivots and
levers) to a restraining and deforming handle 1924. Movement of
hold down clamp die 1922 may be actuated by enactment of
restraining and deforming handle 1924 from a first position to a
second position and vice versa. When restraining and deforming
handle 1924 is placed in the first position, hold down clamp die
1922 may simultaneously be actuated to achieve a non-clamped
position in a non-clamped state. When restraining and deforming
handle 1924 is placed in the second position, hold down clamp die
1922 may simultaneously be actuated to achieve a clamped position
in a clamped state.
[0086] In one disclosed embodiment, restraining and deforming
handle 1924 is attached to a base 1926 of restraining and device
deforming clamp assembly 1914 shown in FIG. 25. Restraining and
deforming handle 1924 may include a handle support bracket 1928
pivotably attached to a base support brackets 1932 such as via
pins. Base support brackets 1932 are secured to base 1926 such as
via fastening members 1934. One end 2104 of a lever 1936 may also
be pivotably attached to base support brackets 1932 such as via pin
assembly 1930. A press support 1938 may be disposed and pivotably
attached between handle support brackets 1928. A position of press
support 1938 may also include being disposed above a contact
surface 1940 of lever 1936. Another end 1942 of lever 1936 may be
attached to hold down clamp die 1922. In one disclosed embodiment,
hold down clamp die 1922 is engaged with end 1942 of lever 1936 via
a threaded fastener assembly 1944. Threaded fastener assembly 1944
may comprise a threaded fastener 1946 extending from hold down
clamp die 1922 through end 1942 and secured thereto via a
corresponding threaded nut 1948. In some select embodiments, a
threaded nut 1948 may be disposed along threaded fastener 1946
above and below hold down clamp die 1922. Threaded fastener
assembly 1944 allows for adjustment and manipulation of hold down
clamp die 1922 which may also include an ability of adjusting an
applied clamping force. In at least one embodiment, restraining and
deforming handle 1924 moves to urge hold down clamp die 1922 toward
the receiver and the seated auto-injector 100. For example, in some
embodiments, the restraining and deforming handle 1924 moves to
urge hold down clamp 1922 toward the auto-injector (e.g., in a
direction generally perpendicular to a longitudinal axis of
auto-injector 100). However, it is contemplated that other designs
may be employed. For example, such designs may include a
configuration wherein restraining and deforming handle 1924
operates in a different direction such as parallel to the seated
longitudinal axis of auto-injector 100 and/or in tandem with clamp
handle 1952 and/or extractor handle assembly 1916.
[0087] In operation, a forward rotational movement about the long
axis of service table 1902 enables press support 1938 to abut
contact surface 1940 thereby urging lever 1936 generally
downwardly. The downward motion is translated to hold down camp die
1922 to achieve a pressing operation, for example, against an outer
body 110 of an auto-injector 100 disposed within hold down cavity
1912, as explained below.
[0088] Extractor handle assembly 1916 comprises a base portion 1950
to which an extractor clamp handle 1952 is pivotably attached such
as by pin assembly 1954. A linkage assembly 1956 is configured to
couple a shaft extension 1958 at one end 1960 to a bracket support
1962 of extractor clamp handle 1952 such as via pin assembly 1964.
The other end 1966 of shaft extension 1958 may be coupled to an
extractor clamp assembly 1968. In some embodiments, the extractor
handle assembly 1916 and extractor clamp assembly 1968 serve as an
extractor to facilitate removal of the power pack 130 from the
auto-injector 100.
[0089] Extractor clamp assembly 1968 may comprise complementary
clamping members 2108, 2110 pivotally connected to a support
bracket assembly, as seen in FIG. 26. The support bracket assembly
may comprise a bottom support bracket 2118 and a top support
bracket 2140. Clamping members 2108, 2110 may be connected to
support bracket assembly via fastener or pin assemblies 2124. In
one disclosed embodiment, a cam assembly 2958 may be employed to
pivot forward ends 2126, 2128 of complementary clamping members
2108, 2110, respectively, together. Such motion may clamp together
forward ends 2126, 2128 to sides of outer body 110, as described
below. Cam assembly 2958 may be engaged by rotating cam knob 2138.
As illustrated, for example, in FIGS. 21, 27 and 29, each of
complementary clamping members 2108, 2110 may be coupled to shaft
extension 1958 via shaft coupling assembly 2130. In one embodiment
shaft extension 1958 may be internally threaded to receive a mating
threaded fastener 2950. Thus an end 2750 of shaft extension 1958
may be placed in abutment with collar 2952 of shaft coupling
assembly 2130. Threaded fastener 2950 is inserted through a
receiving hole 2752 in collar 2952 and into a complementary
threaded receptacle 2754 of shaft extension 1958 thereby retaining
shaft coupling assembly 2130 to shaft extension 1958. Cam knob 2138
may be coupled to cam portion 2756 such as via fastener 2758 to
induce rotation as described below.
[0090] FIG. 29 illustrates extractor clamp assembly 1968 having the
top support bracket 2140 and cam knob 2138 removed. A biasing
member 2956, such as an elastic member, or O-ring, or spring, is
coupled to each of clamping members 2108, 2110 such as via
fasteners 2972. A cam assembly 2958 is disposed between clamping
members 2108, 2110. In a select embodiment, cam assembly 2958 may
comprise a cam design having generally oval configuration with two
elongated end points 2960, 2962 along a first axis which are
generally longer than two shorter end points 2964, 2966 along a
second axis wherein the second axis is generally perpendicular to
the aforementioned first axis. When rotated, the longer end points
2960, 2962 may contact interior contact surfaces 2968, 2970 of
clamping members 2108, 2110, respectively. This causes forward ends
2126, 2128 of complementary clamping members 2108, 2110,
respectively, to pivot toward one another. Continual rotation of
cam assembly 2958 disengages longer end points 2960, 2962 from
contacting contact surfaces 2968, 2970 where upon biasing member
2956 compress and rotate forward ends 2126, 2128 away from one
another.
[0091] Bottom support bracket 2118 may comprise a linkage member
2974 extending, for example, generally toward the top support
bracket 2140. A safety pin 2976 may be configured to extend from
linkage member 2974. In a disclosed embodiment safety pin 2976 is
rigidly secured to linkage member 2974, such as by threaded
connectors.
[0092] Turning to FIG. 37, removal of the power pack 130 from
auto-injector 100 in accordance with disclosed embodiments requires
removal of release pin 120 from outer body 110. Release pin 120 is
removed from an end opening 111 of auto-injector 100. The recesses
111a (not shown) and 111b provide access to downwardly extending
tabs 121a and 121b, respectively, of release pin 120. The tabs 121a
and 121b are primarily received in retention recesses 235 (not
shown) located on opposing sides of the power pack 130. As
described earlier, hole 234 is provided in an end surface of the
power pack 130 which is sized to receive the downwardly extending
pin 125 of the release pin 120.
[0093] Auto-injector 100 is now prepared for removing its internal
power pack 130 via apparatus 1900. The prepared auto-injector 100
is disposed within cavity 1910. A bottom end 2136 is abutted
against end stop 2102 for support. Handle 1924 may be pulled
forward to position hold down clamp die 1922 against outer body
110. Abutting pressure caused by hold down clamp die 1922 steadily
holds down auto-injector 100 and slightly deforms outer body 110.
The elastic deformation of outer body 110 caused by hold down clamp
die 1922 facilitates dislodgement of projections or teeth 238 on
the power pack 130 from openings 113. Once dislodged, power pack
130 may be removed from outer body 110.
[0094] Extractor handle assembly 1916 is enabled by lowering
extractor clamp handle 1952 wherein extractor clamp assembly 1968
urged towards auto-injector 100 as a coupling device that couples
to the auto-injector 100. Safety pin 2976 is aligned with and
inserted into hole 234 of auto-injector 100. Disclosed embodiments
provide this design feature in order to maintain the safety of the
auto-injector 100 components such as preventing undesirable
deployment of the needle. Forward ends 2126, 2128 are clamped to
side recesses 111a and 111b of outer body 110 by rotating cam knob
2138 to cause end points 2960, 2962 to contact interior contact
surfaces 2968, 2970, respectively. Once positioned and assembled,
extractor clamp handle 1952 of extractor handle assembly 1916 is
pulled in a direction away from auto-injector 100. The clamping
force of forward ends 2126, 2128 is sufficient to grip side
recesses 111a and 111b of outer body 110 for dislodging power pack
130 from auto-injector 100. To dislodge power pack 130 from
auto-injector 100, extractor clamp handle 1952 is pulled away from
auto-injector 100. This motion causes shaft extension 1958 coupled
to extractor clamp assembly 1968 to move axially away from
auto-injector 100, thereby retracting the clamped power pack 130
from outer body 110. Once power pack 130 is removed from
auto-injector 100, safety pin 2976 may also be removed from hole
234.
[0095] FIGS. 29-34 illustrate another embodiment of the disclosed
apparatus 1900 wherein a mandrel 3402 is introduced within the
extractor clamp assembly 1968 as an exemplary coupling device. In
this disclosed embodiment, a mandrel 2116 is configured to be
disposed between extended forward portions 2120, 2122 of
complementary clamping members 2108, 2110, respectively. In a
select design, an extension 3404 is coupled to linkage member 2974
extending generally perpendicular to assembled complementary
clamping members 2108, 2110. Extension 3404 is connected to mandrel
2116 such that as shaft extension 1958 is withdrawn and extended,
mandrel 2116 moves accordingly.
[0096] FIGS. 35-36 detail additional features of a mandrel safety
pin assembly 2600 utilized by the apparatus 1900. Mandrel safety
pin assembly 2600 may include mandrel safety cap 2606. Mandrel
safety cap 2606 is dimensioned and sized to fit opening 111 of
outer body 110. It is designed to orient components of
auto-injector 100 during the disclosed disassembly procedure.
Additional features of mandrel safety cap 2606 may include
designing its exterior side surface outer walls 2626 to be flush
with the exterior outer walls of outer body 110. One or more
flanges 2628 may be configured to extend away from underside 2610,
such as, along an inside perimeter of exterior side surface outer
walls 2626. In one disclosed embodiment, the positioning of flanges
2628 is configured to position and generally abut its exterior wall
2628 against the interior wall of outer body 110 when expanding
mandrel safety cap 2606 is inserted within opening 111. The
positioning and size dimensions of flanges 2628 provide structural
support from within the interior of auto-injector 100 walls. At the
same time, the positioning and size dimensions of flanges 2628 may
be configured such that exterior side surface outer walls 2626
remain flush with exterior outer walls of outer body 110 during
assembly.
[0097] An expansion flexure assembly 2608 is configured to extend
away from an underside 2610 of expanding mandrel safety cap 2606.
Expansion flexure assembly 2608 may comprise a plurality of
expansion flexures 2614 arranged, for example, in a circular
configuration about a hollow diameter. In one disclosed embodiment,
the plurality of expansion flexures 2614 may be configured to
extend from an underside 2610 of expanding mandrel safety cap 2606
in a first circular configuration 2618 having a first exterior
diameter. End portions 2620 of the plurality of expansion flexures
2614 extending away from underside 2610 may terminate to form a
second circular configuration 2622 having a second exterior
diameter different than the first diameter. In an exemplary
embodiment, the second exterior diameter is larger than the first
exterior diameter. Consequently, a top surface or flanged area 2624
is radially formed by the expanded exterior diameter of the second
circular configuration 2622 of the plurality of expansion flexures
2614.
[0098] A mandrel safety pin 2612 extends through the center of the
hollow diameter of the plurality expansion flexures 2614. Mandel
safety pin 2612 is provided as a safety precaution feature to
replace pin 125 of release pin 120 to prevent unwanted dislodging
of the needle in auto-injector 100. Mandrel safety pin 2612 is
configured to move axially and independently within the hollow
diameter formed by the plurality of expansion flexures 2614 as
indicated by the directional arrows. In one disclosed embodiment,
mandrel safety pin 2612 is integrally connected to coupling member
2604 such that mandrel safety pin 2612 is inserted through an
internal bore of mandrel 2116, expanding mandrel safety cap 2606
and expansion flexure assembly 2608. In one disclosed embodiment, a
portion 2616 of the diameter of mandrel safety pin 2612 may be
configured to a greater external diameter dimension than the
internal diameter of the hollow diameter formed by the circular
configuration 2618 of the plurality of expansion flexures 2614.
Thus, as the portion 2616 having the greater external diameter
dimension moves axially within the internal hollow diameter,
portion 2616 expands the plurality of expansion flexures 2614 upon
contact. Consequently, the flanged area 2624 is also deflected to
radially expand and increase.
[0099] Turning to FIG. 37, as described earlier, removal of the
power pack 130 from auto-injector 100 in accordance with disclosed
embodiments requires removal of release pin 120 from outer body
110. Release pin 120 is removed from an end opening 111 of
auto-injector 100. The recesses 111a (not shown) and 111b provide
access to downwardly extending tabs 121a and 121b, respectively, of
release pin 120. The tabs 121a and 121b are primarily received in
retention recesses 235 (not shown) located on opposing sides of the
power pack 130. As described earlier, hole 234 is provided in an
end surface of the power pack 130 which is sized to receive the
downwardly extending pin 125 of the release pin 120.
[0100] In accordance with the described alternate embodiment, in
operation, expanding mandrel safety cap 2606 is designed to replace
existing safety release pin 120. FIG. 38 illustrates a cut-away
view 2900 of the expanding mandrel safety pin assembly 2600 in
connection with the power pack 130 of auto-injector 100, according
to an embodiment of the present disclosure. As shown in FIG. 38,
removed safety release pin 120 is replaced with expanding mandrel
safety cap 2606 at end opening 111 of auto-injector 100. The
expanding mandrel safety pin assembly 2600 is attached to the power
pack 130 assembly by inserting expansion flexure assembly 2608
comprising the plurality of expansion flexures 2614 through hole
234. Once expansion flexures 2614 have breached through the
interior top 2902 of power pack 130 through hole 234, mandrel
safety pin 2612 is inserted axially through expansion flexure
assembly 2608. Due to the greater external diameter of portion
2616, retracting mandrel safety pin 2612 through expansion flexure
assembly 2608 causes the plurality of expansion flexures 2614 to
expand and to be deflected radially outwardly thereby creating a
larger diameter of the exterior circumference 2904 of expansion
flexure assembly 2608 than the interior diameter of hole 234 of
power pack 130. The auto injector 100 may then be prepared for
removal of its internal power pack 130 as described above.
[0101] Extractor handle assembly 1916 is enabled by lowering
extractor clamp handle 1952 to latch expanding mandrel safety cap
2606. Expanding mandrel safety pin assembly 2600 is attached to
extractor clamp assembly 1968, such as via support bracket 2118.
Forward ends 2126, 2128 are clamped to side recesses 111a and 111b
of outer body 110. Once positioned and assembled, extractor clamp
handle 1952 of extractor handle assembly 1916 is pulled in a
direction away from auto-injector 100 to dislodge power pack 130
from auto-injector 100. During the dislodging step, expansion
flexure assembly 2608 is withdrawn to be dislodged from within hole
234 through an opposite movement/direction from which it was
inserted. As described above, retraction of the inserted mandrel
safety pin 2612 through expansion flexure assembly 2608 causes the
plurality of expansion flexures 2614 to expand and to be deflected
radially outwardly thereby creating a larger diameter of the
exterior circumference 2904 of expansion flexure assembly 2608 than
the interior diameter of hole 234 of power pack 130. In some
disclosed embodiments, mandrel safety pin 2612 may be configured as
a chamfered/angled mandrel that engages the plurality of expansion
flexures 2614 to expand when insert through the expansion flexure
assembly 2608. Withdrawal of expansion flexure assembly 2608 from
within hole 234 causes contact surfaces 2906 of the expanded
plurality of expansion flexures 2614 to abut interior top 2902 of
power pack 130. The materials and design of the expanded plurality
of expansion flexures 2614 are sufficiently strong to engage,
support pulling and dislodging power pack 130 and spring assembly
530 from outer body 110 of auto-injector 130 when sufficient
withdrawal force is applied by extractor handle assembly 1916. A
needle may be attached to a drug reservoir, for example, which is
attached via vacuum to a rubber plunger head that comes out with
the power pack 130.
[0102] FIG. 39 illustrates an exemplary power pack 130 removed from
the auto-injector body by the disclosed apparatus 1900 wherein
release pin 120 has been reinserted into opening 111. Once power
pack 130 is removed, auto-injector 100 may be serviced. For
example, servicing may include replacing and/or refilling of the
cartridge of auto-injector 100 with medicament. After refilling,
power pack 130 may be reinserted within outer body 110 of
auto-injector 100, for example, in accordance with the embodiments
described herein. Thus, reinstallation of power pack 130 may
include urging projections or teeth 238 on the power pack 130 to
snap fit into openings 113 as described earlier. The snap fit
prevents the removal of the power pack 130 from the outer body 110
once installed in the outer body 110. Once inserted, the power pack
outer body 230 is not movable with respect to the outer body
110.
[0103] Exemplary servicing techniques 3100 for refilling medicament
in auto-injector 100 are presented in the flowchart of FIG. 40. In
one disclosed embodiment, an auto-injector 100 is presented and
received for servicing 3102. An initial inspection 3104 of
auto-injector 100 may occur to determine if it is structurally
sound and/or serviceable. If a determination is made that
auto-injector 100 is not serviceable 3106, a user is notified 3108
and servicing of the auto-injector 100 is rejected. If a
determination is made that auto-injector 100 is serviceable 3110,
an exemplary technique may be employed, for example, for refilling
auto-injector 100.
[0104] To begin, power pack 130 of auto-injector 100 is removed by
the disclosed apparatus 1900. In some embodiments, once the power
pack 130 is removed, one or more remaining components of the
auto-injector 100 may be retained within the apparatus 1900. A
service technician is presented with options for emptying any
remaining medicament 3112 from auto-injector 100. Removal of the
same may occur via needle lumen 3114, removing the internal plunger
and disposing of any remaining medicament 3116 or disposing of the
cartridge. Refilling techniques 3120 may be based upon the specific
emptying technique 3112 employed by the service technician. For
example, based upon removal of medicament via needle lumen 3114,
medicament may also be refilled by needle lumen 3120. Based upon
removal of medicament by removing the internal plunger and dumping
any remaining medicament 3116, medicament may be refilled by rack
filling auto-injector 100 through the open end 3120. Based upon
removal of medicament by disposing of the reservoir 3118,
medicament may be refilled by obtaining a new or refilled
medicament cartridge 3120. Given the technique for disposing of the
reservoir 3118 and refilling auto-injector 100 with a new or
refilled medicament cartridge 3120, additional servicing operations
may be employed and/or necessary. Such options may include
employing prescribed sanitization options 3122 to ensure safety and
health standards for medical distribution. Once auto-injector 100
is refilled with medicament, power pack 130 is reinserted into
auto-injector 100 and closed for updated and continued use.
[0105] Having described the many embodiments of the present
disclosure in detail, it will be apparent that modifications and
variations are possible without departing from the scope of the
disclosure defined in the appended claims. Furthermore, it should
be appreciated that all examples in the present disclosure, while
illustrating many embodiments of the disclosure, are provided as
non-limiting examples and are, therefore, not to be taken as
limiting the various aspects so illustrated.
[0106] All documents, patents, journal articles and other materials
cited in the present application are incorporated herein by
reference.
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